FDA Examines Laser Eye Surgery Complaints
A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer look at grievances from patients, including blurred vision and dry eyes.
An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.
But the society of eye surgeons who perform Lasik says 95 percent of patients are satisfied with their results. The group is expected to tell regulators later this week that most side effects from Lasik surgery are rare and temporary.
FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.
The agency will ask the expert panel whether educational materials given to patients considering Lasik need to be changed or updated, according to documents posted to the agency's Web site Wednesday.
Regulators agreed to hold the meeting after years of complaints from a small group of patients who say their eyesight has been irreparably damaged by the surgery. The agency received 140 reports of Lasik-related problems between 1998 and 2006, according to an agency spokeswoman.
Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998.
"My life is a blur," Kantis said. "When I look at a computer screen I see two pages; when I look up at the moon, I see three of them."
Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks.
"Just before the procedure they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.
An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients. Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.
Investors will be watching Friday's meeting to gauge what impact concerns could have on Lasik laser manufacturers, which San Diego Laser vision correction surgery include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb.
Analysts already expect Lasik procedures to decline 5 to 15 percent this year as economic conditions make the procedure, which costs between $1,500 and $5,000, less financially feasible for many consumers.
The industry's largest player, Advanced Medical Optics, cut its 2008 earnings outlook earlier this year on the expectation of fewer procedures.
But Wachovia analyst Larry Biegelsen said Friday's FDA meeting could prove beneficial for the industry if it shows patient outcomes are relatively positive.
In a note earlier this month, Biegelsen wrote that a new analysis of 2,200 Lasik patients should provide "a good defense" for companies and physicians. The results, which eye doctors will present Friday, show 95 percent of patients across 19 studies were satisfied with their vision following surgery.
Biegelsen rates Advanced Medical Optics "market perform."
Shares of Advanced http://www.lasereyecenter.com/procedures/lasik/ Medical Optics Inc. fell 35 cents, or 1.7 percent, to $19.93 Wednesday while Alcon Inc. shares rose $1.74 to $153.30
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